Kornimate/medical-research-clean huggingface dataset:
home treatment for acute psychiatric care

Conditions: Mental Disorders

Summary: this study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. a one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. the primary focus is on checking whether optional home treatment leads to a reduction of inpatient days during a two-year follow-up period. in addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care. furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses and the clinical ratings made by the staff members of the mental hospital under routine everyday conditions.

this study aims to evaluate whether psychiatric home treatment is an effective and efficient alternative to acute inpatient care in mental hospitals. a one-year prevalence cohort of psychiatric patients in need of hospitalization are randomly assigned to either treatment at inpatient wards (treatment as usual) or a new care model with the additional option of treating patients at their homes by mobile care teams. the primary focus is on checking whether optional home treatment for crisis intervention leads to a reduction of inpatient days during a two-year follow-up period. in addition, the two service models will be compared regarding treatment cost and outcomes as well as satisfaction of patients and their relatives with psychiatric care. furthermore, a sub-cohort of randomly chosen patients from the prevalence-cohort will be examined by a highly trained clinical assessor to test and verify the diagnoses (scid-i and scid-ii) and the clinical ratings (honos) made by the staff members of the mental hospital under routine everyday conditions.

Eligibility criteria:
inclusion criteria: * need for acute psychiatric inpatient care * residence in the canton of aargau * living within 30 minutes (by car) from the headquarters of the home treatment team * health insurance with tarifsuisse exclusion criteria: * insufficient proficiency in german * main diagnosis f0 or f1 (icd-10) * patients of the forencic departement * patients of the child and adolescent department
utility of exercise-induced n-terminal (nt) pro-brain natriuretic peptide levels in predicting prognosis in asymptomatic aortic stenosis

Conditions: Aortic Stenosis

Summary: one hundred patients with moderate to severe asymptomatic aortic stenosis (as) will be asked to exercise on a treadmill. nt-pro-bnp levels will be drawn before and after exercise. changes in nt-pro-bnp levels will be correlated to outcomes at one year. in the pilot phase an additional 10 control subjects without as will be enrolled to document the control response of nt-pro-bnp elevations with exercise.


Eligibility criteria:
inclusion criteria: 1. valvular as (doppler velocity ≥ 3.0 m/s) 2. no baseline symptoms referable to valvular heart disease 3. able to perform ett exclusion criteria: 1. more than mild aortic regurgitation, mitral regurgitation/ stenosis, or tricuspid regurgitation/stenosis 2. previous avr 3. known coronary artery disease 4. creatinine clearance 50 ml/min 5. lvef \< 50% 6. planned valve surgery prior to enrollment 7. significant pulmonary disease 8. unable to give informed consent 9. pregnancy

Keywords: aortic stenosis prognosis brain natriuretic peptide
a pilot study of virtual reality and antigravity treadmill for gait improvement in parkinson

Conditions: Parkinson Disease; Gait Disorders, Neurologic

Summary: the aim of this study is to improve knowledge about mechanical gait assistance combined with virtual reality efficiency in gait recovery for parkinson´s patients. it is hypothesised that 12 sessions of 30 minutes each, over a 4 weeks period, of antigravity treadmill rehabilitation combined with virtual reality treatment is effective for increase gait autonomy in patients with parkinson's disease.


Eligibility criteria:
inclusion criteria: * having parkinson's disease diagnosed by a neurological doctor. * having an alteration of the gait caused by the neurological disorder. * being able to have an independent and voluntary walk of 10 meters as minimum. * height more than 150 cm. exclusion criteria: * being blind. * medical contraindications for walking. * being amputee. * alcohol or drugs abuse. * other diseases that impedes the intervention.

Keywords: parkinson virtual reality anti-gravity treadmill rehabilitation gait disorders
pbfs guided aitbs over language network for asd child

Conditions: Autism Spectrum Disorder; Language Delay

Summary: the aim of this trial is to evaluate the efficacy and safety of precision neuromodulation in improving language ability in children with autism spectrum disorder (asd) who also have language development delay. the neuromodulation will be delivered using the accelerated intermittent theta burst stimulation (aitbs) protocol, targeting the language network in the left superior frontal gyrus (sfg), guided by personalized brain functional sector (pbfs) technology.

autism spectrum disorder (asd) is a neurodevelopmental disorder often accompanied by language delay. emerging evidence indicates that transcranial magnetic stimulation (tms) has been effective in restoring language ability in post-stroke aphasia, but its efficacy in developmental language disorders remains unknown. by leveraging the personalized brain functional sector (pbfs) technique and task-free functional mri scans, we can accurately locate the individual language function brain network. considering the accessibility and comfort of neuromodulation, we will stimulate the language network node in the superior frontal gyrus (sfg) for 12 weeks. in this study, participants meeting the inclusion and exclusion criteria will be randomly assigned to either the active or sham itbs (intermittent theta burst stimulation) groups at a ratio of 2:1. the treatment protocol lasts for 12 weeks, with sessions held 5 days a week and 3 itbs sessions over the sfg per day. the inter-session interval is set at 50 minutes, along with speech therapy. clinical evaluations focusing on language and asd symptoms will be conducted at baseline, after the 12-week treatment period, and at 24-week follow-up after the start of treatment.

Eligibility criteria:
inclusion criteria: 1. professionally diagnosed with asd per dsm - 5 criteria. 2. aged 3 - 6.5 years, either gender. 3. ados-2 results meet asd standard cut - off. 4. scq score: ≥15 (age ≥ 4 years) or ≥11 (age \< 4 years). 5. co-existing language disorder not explaining asd symptoms. no organic speech organ lesions. cnbs-r2016 and clas-tp language-related equivalent age \> 18 months; any clas-tp dimension score \< 6. 6. mandarin is the daily communication language. 7. may have intellectual/global developmental delay not explaining asd symptoms. 8. guardians volunteer, can cooperate in treatment and sign informed consent. exclusion criteria: 1. identified genetic pathogenic factors; current/past comorbid severe disorders (adhd, tourette's, etc.). 2. serious self-harm in the past year. 3. severe sensory/motor disorders precluding cooperation. 4. history of epileptic seizures. 5. serious organic diseases, especially brain related. 6. contraindications for mri/tms (metal/implants). 7. respiratory/circulatory diseases with sedation risk. 8. illiterate guardians unable to handle informed consent/questionnaires. 9. received neuromodulation in the past 3 months. 10. currently in other clinical trials. 11. deemed unfit by the researcher.

Keywords: asd language delay aitbs precision neuromodulation
study of methacholine chloride inhalation challenge in children with bronchial asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the safety and efficacy of sk-1211 inhalation challenge in children with bronchial asthma.


Eligibility criteria:
inclusion criteria: * diagnosis of bronchial asthma * fev1/fvc must be 70% or more * \<10% decrease in fev1 in response to inhalation of normal saline exclusion criteria: * moderate or severe airflow limitation（fev1\<60% predicted） * heart attack or stroke in last 3 months * uncontrolled hypertension, systolic bp\>200, or diastolic bp\>100 * known aortic aneurysm
the use of sodium bicarbonate in the prevention of contrast induced nephropathy

Conditions: Contrast Induced Nephropathy

Summary: preliminary studies have shown a benefit of sodium bicarbonate infusion in decreasing the risk of contrast induced nephropathy with coronary angiography. the investigators plan to randomize 478 patients (with serum creatinine 1.5 mg/dl or greater) undergoing coronary angiography to intravenous isotonic saline or intravenous isotonic sodium bicarbonate beginning one hour before the procedure and for four hours after. the primary endpoint is the development of contrast nephropathy within 48-72 hours after the procedure. patients with an ejection fraction \<30%, overt chf, hypokalemia and alkalemia will be excluded.


Eligibility criteria:
inclusion criteria: * serum creatinine greater then or equal to 1.5 exclusion criteria: * ef\<30 * overt chf * alkalemia * hypokalemia * gfr\<20 cc/min
canadian pegvisomant compassionate study in acromegalic patients

Conditions: Acromegaly

Summary: the purposes of this study are: 1) to provide somavert for compassionate use to patients with acromegaly or who have completed clinical trials and were responsive, and 2) to evaluate the safety and tolerability of somavert.


Eligibility criteria:
inclusion criteria: * subjects must have participated and completed the previous pegvisomant studies or have shown to be unresponsive to other conventional therapies exclusion criteria: * alt/ast\>3 times the uln or have hepatic disease * have severe visual field loss, cranial nerve palsies or intracranial htn that requires surgery to decompress the tumor * unwilling to self-administer the medication.
an rct evaluation of a diabetes dashboard team model in primary care

Conditions: Diabetes

Summary: to compare a comprehensive diabetes team care condition (ic) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (udc) that does not have access to the diabetes dashboard.

to compare a usual diabetes care condition (udc) to a comprehensive diabetes care intervention condition (ic) involving a "diabetes dashboard" clinical decision support tool used by the diabetes team in primary care. the investigators used a parallel-groups randomized design. the diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (hba1c \>7.5%) latino t2d patients (mean age=55 years, 60% female) seen at 2 urban community health centers. this intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).

Eligibility criteria:
inclusion criteria: * age 18 years or older, * self-identified hispanic ethnicity, * diagnosis of t2d, * hba1c \>7.5%, and * provider approval given for patient participation exclusion criteria: * inability to consent, * pregnant or planning to become pregnant in the next year, * taking glucocorticoid therapy, or * having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

Keywords: hispanic clinical decision support diabetes hba1c psychosocial
clinical trial to investigate safety and efficacy of edoxaban in patients with cteph (kabuki)

Conditions: CTEPH

Summary: this is phase iii trial to evaluate whether edoxaban, a direct factor xa inhibitor, is noninferior to warfarin in preventing worsening of chronic thromboembolic pulmonary hypertension (cteph).


Eligibility criteria:
inclusion criteria: 1. patient who once\* diagnosed with cteph based on at least 2 imaging study (vq scan, ct pulmonary angiogram, or catheter-based pulmonary angiogram) and hemodynamic criteria (mpap \>=25 mmhg and pawp =\< 15 mmhg). \*patients treated with pea, bpa, or vasodilators, who do not meet hemodynamic criteria at the registration, are eligible. 2. patients who are not planned to require increased / changed / discontinuation of pea, bpa, or pulmonary vasodilators within 12months 3. stable administration of vitamin k antagonists 4. who functional class i-iii 5. patients who meet a) b)and c) by 90 days prior to baseline. a)no addition, reduction, or change of endothelin antagonists, soluble guanylate cyclase stimulants, phosphodiesterase-5 inhibitors, prostacyclin, and its derivatives, or calcium antagonists. b)appropriate anticoagulants have been continued. c)no bpa has been done. 6. patients who have not undergone pea from 180 days prior to baseline right heart catheterization to the start date of study drug administration 7. patients with a 6-minute walking distance \>=150m exclusion criteria: 1. patients with severe lung disease (fev1.0/fvc \< 60% or %tlc \< 60%) 2. patients with acute or chronic disabilities that interfere with clinical trial requirements 3. patients with acute symptomatic pe within 180 days prior to the start of study drug administration 4. patients with congenital heart disease who have not undergone radical surgery 5. patients who cannot provide informed consent due to mental disorders, dementia, or other illnesses 6. patients with advanced cancer 7. patients with a life expectancy of less than 1 year 8. patients with active hemorrhagic lesions 9. patients with comorbidities requiring vitamin k antagonist 10. patients receiving other study drug within 30 days prior to randomization 11. patients with renal dysfunction (ccr 15 ml/min) 12. patients with liver dysfunction (child-pugh b or c) 13. females of reproductive age not using an acceptable form of contraception/pregnant/breastfeeding 14. patients contraindicated for edoxaban or warfarin 15. patients with hypersensitivity to any of the drug

Keywords: edoxaban doac wafrarin anticoagulation
an open-label study of alpn-202 in subjects with advanced malignancies

Conditions: Advanced Solid Tumor; Lymphoma

Summary: this is a cohort-based, open-label dose escalation and expansion study in adults with advanced solid tumors or lymphoma, refractory or resistant to standard therapy, or without available standard or curative therapy.


Eligibility criteria:
key inclusion criteria: 1. adult 18 to 75 years old at screening 2. pathologically-confirmed, locally advanced or metastatic unresectable solid tumor of an acceptable histology part a (dose escalation) 1. that is refractory or resistant to standard therapy, including checkpoint inhibitor(s) if approved 2. or for which standard or curative therapy is not available part b (dose expansion) 1. metastatic cutaneous melanoma 2. pd-l1-positive cancers (other than cutaneous melanoma or renal cell carcinoma) 3. metastatic renal cell carcinoma 3. protocol-defined measurable disease 4. available tumor biopsy representative of current disease 5. ecog performance status grade 0-2 6. life expectancy of ≥ 3 months 7. recovery to ≤ grade 1 for any non-laboratory toxicity resulting from previous anticancer therapy prior to first dose of alpn-202 (except alopecia, hearing loss, ≤ grade 2 neuropathy or endocrinopathy managed with replacement therapy) 8. adequate baseline hematologic, renal, and hepatic function key exclusion criteria: 1. history of ≥ grade 3 immune-related adverse event leading to treatment discontinuation 2. active or prior pneumonitis or interstitial lung disease 3. presence of any active central nervous system metastases 4. prior organ allograft or allogeneic hematopoietic stem cell transplantation 5. any serious or uncontrolled health condition, which, in the opinion of the investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results. 6. receipt of any protocol-restricted therapy within the timeframes indicated: 1. pd-l1 inhibitors: 5 half-lives (e.g., atezolizumab, 135 days; avelumab, 31 days; durvalumab, 85 days) 2. chemotherapy, small molecule anticancer agents (e.g., kinase inhibitors), or radiation: 2 weeks 3. other monoclonal antibodies, antibody-drug conjugates, bispecific antibodies, antibody like drugs, cytokines, cell therapies, or radioimmunoconjugates: 4 weeks 7. any active, known, or suspected autoimmune disease 8. systemic treatment with corticosteroids (\> 10 mg/day prednisone) or other immunosuppressive medication 9. any second malignancy active within the previous 3 years 10. active infection requiring therapy at the time of the first dose of alpn-202. 11. known seropositivity for or active infection by human immunodeficiency virus, hepatitis b or c. 12. known allergies, hypersensitivity, or intolerance to alpn-202 or excipients in the drug product formulation. 13. history of grade 4 infusion-related, anaphylactic or allergic reaction to any previous fc-based protein therapy.
comparison of postoperative pain and neuropathy at cesarean sectio with blunt or sharp fascia incision

Conditions: Postoperative Pain

Summary: the purpose of this study is to compare sharp and blunt fascial entry during caesarean section.

the patients will be divided into two group, the fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. the study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. the following parameters are evaluated for each patients 1. all patients are evaluated for postoperative pain with vas score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus

Eligibility criteria:
inclusion criteria: * woman having caesarean section for the first time * woman, who have had no previous lower abdominal surgery * woman who can give informed consent exclusion criteria: diabetes mellitus (this does not include gestational diabetes) * infection * regular treatment with immunosuppressives * alcohol or drug abuse * age under 18 years old * chronic pain disease eg. fibromyalgia, rheumatoid arthritis * bmi over 35

Keywords: cesarean section facial incision postoperative pain
a comparison of bed rest versus moderate activity in preterm premature rupture of membranes (pprom)

Conditions: Preterm Premature Rupture of the Membranes; Physical Activity

Summary: bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. in this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (pprom).

historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. the definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). recent studies have highlighted potential harmful effects from bed rest. however, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies. pprom is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the unites states. women with pprom are routinely managed in the inpatient setting from the time of diagnosis until delivery. therefore, pprom patients are a closely supervised and easily accessible cohort of women. in this study, participating patients with pprom will be randomized into two groups: bedrest or moderate activity. maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.

Eligibility criteria:
inclusion criteria: * pregnant * gestational age between 23 weeks 0 days - 32 weeks 0 days * diagnosed with preterm premature rupture of membranes exclusion criteria: * cervical dilation greater than or equal to 3cm * active labor * evidence of infection * inability to provide informed consent * requirement for continuous fetal monitoring

Keywords: preterm premature rupture of the membranes bedrest physical activity
study of the survival of recombinant human neuregulin-1β in chronic heart failure (chf) patients

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to evaluate efficacy of rhnrg-1 in reducing the death rate of heart failure.

the mortality of chronic heart failure patients remains high, in spite of recent treatment. rhnrg-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. both the preclinical trial and phase ii clinical trail have confirmed that rhnrg-1 effectively enhance the heart function and reverse the remodeling of left ventricular in heart failure animals and humans. in this study, we will evaluate efficacy of rhnrg-1 in reducing the death rate of heart failure.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80, both sex. 2. left ventricular ejection fraction (lvef)≤40% (echo). 3. nyna functional class iii\~ⅳ. 4. clinical symptom is steadily in the latest 1 week (no fluid retension, no weight gain). 5. capable of signing the informed consent form. exclusion criteria: 1. patients with acute pulmonary edema or acute hemodynamic disorder. 2. patients with right heart failure caused by pulmonary disease. 3. patients diagnosed with pericardial effusion or pleural effusion. 4. patients with myocardial infarction during the preceding 3 months. 5. patients with constrictive pericarditis, significant valvular pathological change or congenital heart diseases, severe pulmonary artery hypertension. 6. unstable angina pectoris. 7. cardiac surgery or cerebrovascular accident within recent six months. 8. preparing for heart transplantation. 9. serious ventricular arrhythmia (multi-morphological premature ventricular contraction, frequent paroxysmal ventricular tachycardia). 10. serious hepatic or renal dysfunction caused by organic pathological changes (cr\>3.0mg/dl, ast or alt 10 times above the normal upper limit). 11. serum potassium \ 5.5 mmol/l. 12. systolic blood pressure \ 160mmhg. 13. pregnant or plan to pregnant. 14. patients who participated in any clinical trial in the recent three months. 15. subject with a life expectancy less than 3 months as assessed by the investigator. 16. serious nervous system diseases (alzheimer's disease, advanced parkinsonism). 17. history of any malignancy or suffering from cancer,or biopsy proven pre-malignant condition (eg dics or cervical atypia). 18. evidence (physical examination,cxr,echo or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm has effect on heart function or endocrine system, eg pheochromocytoma or hyperthyroidism. 19. judging by the investigator, the patients could not complete the study or adhere to the study requirements (due to the management reasons or others).

Keywords: chronic heart failure rhnrg-1 mortality